Atopic DermatitisPhase 3NCT00231998
Extension Study of Pimecrolimus Cream in Pediatric Patients With Atopic Dermatitis
A Phase 3 study testing Pimecrolimus in people with Atopic Dermatitis, run by Novartis at 1 site in Japan.
Trial summary
Pimecrolimus, which is an ascomycin derivative, is an anti-inflammatory non-steroidal agent. In this study, the long-term safety and efficacy of Pimecrolimus cream will be evaluated in Japanese pediatric patients with atopic dermatitis. This study is a 6-month extension study following core study. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Pimecrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteJapan
- Study dates
- May 2004to Jun 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- Child
Who may be able to join
- - Patients who had completed the core study and whose participation in this study was considered appropriate as judged by the investigator
- Patients whose guardians have given written informed consent to participation in this study
Who cannot join
- - Patients who failed in treatment compliance in the core study
- Patients who had a major violation of the protocol in the core study
Trial locations and contacts
1 site in 1 country.
Japan1 site
This study is not being conducted in the United States
Various Cities
About this study
Official title: A Clinical Study Continued From the Confirmatory Study to Validate the Efficacy and Safety of Pimecrolimus Cream in Pediatric Atopic Dermatitis Patients
Pimecrolimus, which is an ascomycin derivative, is an anti-inflammatory non-steroidal agent. In this study, the long-term safety and efficacy of Pimecrolimus cream will be evaluated in Japanese pediatric patients with atopic dermatitis. This study is a 6-month extension study following core study.
THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES
- Conditions
- Atopic Dermatitis
- Being tested
- Pimecrolimus
- Keywords
- Atopic dermatitis, ASM981, pimecrolimus
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PimecrolimusDrug
Also called Elidel
Pimecrolimus cream 1 %
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Pimecrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by adverse events (AEs)
Secondary outcomes (1)
Number of flares during 26 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startMay 2004
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals Japan, Study chair, Novartis Pharmaceuticals Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231998
- Sponsor's protocol ID
- CASM981C1302
- Status last verified
- Dec 2007
- First submitted
- 3 Oct 2005
- Last updated
- 17 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Continued From the Confirmatory Study to Validate the Efficacy and Safety of Pimecrolimus Cream in Pediatric Atopic Dermatitis Patients
- ClinicalTrials.gov ID
- NCT00231998
- Acronym / sponsor ID
- CASM981C1302
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, ASM981, pimecrolimus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Study completion
- Jun 2005 (actual)
- First posted
- 4 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pimecrolimus, which is an ascomycin derivative, is an anti-inflammatory non-steroidal agent. In this study, the long-term safety and efficacy of Pimecrolimus cream will be evaluated in Japanese pediatric patients with atopic dermatitis. This study is a 6-month extension study following core study.
THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Pimecrolimus |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (2 listed)
- - Patients who had completed the core study and whose participation in this study was considered appropriate as judged by the investigator
- Patients whose guardians have given written informed consent to participation in this study
Key exclusion criteria (2 listed)
- - Patients who failed in treatment compliance in the core study
- Patients who had a major violation of the protocol in the core study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PimecrolimusAlso: ElidelPimecrolimus cream 1 % | Drug | 1 |
Primary outcome
Safety assessed by adverse events (AEs)
1 secondary outcome
Number of flares during 26 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals Japan study chair
Novartis Pharmaceuticals Japan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pimecrolimus in people with Atopic Dermatitis, run by Novartis at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessed by adverse events (AEs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2007.